Diabetes has become a growing epidemic, yet treatment goals are seldom achieved, and patients endure detrimental complications. Insulin is the only dose-dependent antidiabetic medication in which most patients can accomplish balanced blood glucose levels when adequate dosages are prescribed. Nonetheless, only when insulin dosage is frequently titrated, is the full benefit of the drug realized. The mismatch between patients'needs and caregivers'availability prohibit frequent insulin dosage titrations. Hygieia INC. is developing a device called the "Private-Doc", intended for use by insulin-requiring diabetic patients. Private-Doc will be a pocket-size device, combining a glucose meter with embedded proprietary algorithmic software that analyzes blood glucose levels recorded in the device's memory, and periodically recommends modifications in insulin dosage. The already developed software algorithms are based on the way an endocrinologist evaluates and frequently adjusts insulin in a diabetic patient. The algorithms utility has been evaluated retrospectively using historical data from an intensive insulin therapy trial. Like other glucose meters on the market, Hygieia intends to distribute Private-Doc without cost to the patient, while the cost of consumable glucose test strips will be covered by the medical insurance. In Phase I, Hygieia seeks to prospectively corroborate Private-Doc's software in a 16-week clinical safety and efficacy study, including 60 Type-1 and Type-2 diabetic patients, who are already on insulin therapy, but have poor metabolic control. During the first 4 weeks of the trial (the control period), daily glucose levels and insulin dosages will be documented by the enrolled patients, without modifying their insulin dosages. During the 12-week experimental period that follows, patients will be provided with weekly insulin dosage modifications as recommended by Private-Doc's software algorithms and communicated by the study-team. Efficacy of the insulin dosage modifications will be assessed by hemoglobin A1C, fructosamine and mean weekly glucose data. Safety will be confirmed by frequency of hypoglycemia. Hygieia hypothesizes that Private-Doc software will effectively and safely optimize glucose control in insulin-requiring type-1 and type-2 diabetic patients. Upon validating feasibility of the concept in Phase I, , a prototype hand-held device containing the proprietary software will be tested for safe and effective use by the patients in the home setting in Phase II. We believe that once Private-Doc becomes widely available to insulin- requiring diabetic patients, the overall medical benefit of the individualized insulin dosage optimizer device will be to reduce the incidence of diabetic complications, to alleviate the health system burden and thus potentially save billions of dollars in national health care costs. PUBLIC HEALTH RELEVANCE: Despite immense effort to achieve balanced glucose control, millions of insulin-treated diabetic patients have high glucose levels and develop devastating complications at tremendous annual cost. Hygieia Research developed novel software retrospectively proven capable of optimizing patient's insulin dosage in a similar manner to a group of expert endocrinologists. This study will test the software ability to prospectively treat diabetic patients, thus leading to the development of an intelligent glucose meter that will actively help physicians manage patients, reduce complications of the disease, and save billions of tax payer dollars in health care costs.